Metformin for Cystic Fibrosis-Related Diabetes on CFTR Modulator Therapy

This study is looking at whether metformin hydrochloride can improve how ion channels (tiny tunnels that let charged particles in and out of cells) work in the airways of people with cystic fibrosis (CF) who also have cystic fibrosis-related diabetes (CFRD). You might be able to join if you are over 18, have CF, and have been taking certain CFTR modulator therapies (like ivacaftor or elexacaftor/tezacaftor/ivacaftor) for at least 30 days. You also need to have CFRD and still have high blood sugar even after starting your modulator therapy. The study will look at changes in a specific ion channel (BK channel) gene expression over 14 weeks of metformin treatment. The current status of this study is unclear.

Study design
This is an interventional study planning to enroll up to 30 participants. It involves a dose-escalation of metformin hydrochloride.
What's involved
You would start with a lower dose of metformin hydrochloride, increasing it over two weeks, and then continue at 1000 mg twice daily for 14 weeks. You would also take a daily vitamin B12 supplement for the duration of the trial.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint is measured through week 14 of metformin treatment.

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NCT04530383

Metformin for People With CFRD on CFTR Modulator Therapy to Improve Ion Channel Function

Recruiting
PHASE2Ages 18+InterventionalTreatment
University of Kansas Medical Center
~30 participants
Updated 2026-04-15 on ClinicalTrials.gov
What's tested:Metformin Hydrochloride

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in BK channel gene expression
Measured over Baseline through week 14 of metformin treatment
Cystic Fibrosis-related Diabetes
Cystic Fibrosis
1 sites across 1 states
Kansas1
  • Matthias A Salathe, M.D. · PRINCIPAL_INVESTIGATOR · Professor

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  • Change in BK channel gene expressionBaseline through week 14 of metformin treatment

    Levels of LRRC26 (big potassium channel regulatory subunit) mRNA will be measured by polymerase chain reaction from nasal cells acquired via brushing